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  5. NDC Package Code: 77338-007-04 Astonea Cold Therapy

NDC Package 77338-007-04 Astonea Cold Therapy

Menthol 4% Gel Topical - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
77338-007-04
Package Description:
118.2 g in 1 TUBE
Product Code:
77338-007
Proprietary Name:
Astonea Cold Therapy
Non-Proprietary Name:
Menthol 4%
Substance Name:
Menthol
Usage Information:
Temporary relief from minor aches and pains of sore muscles and joints associated with:arthritisbackachestrainssprains
11-Digit NDC Billing Format:
77338000704
NDC to RxNorm Crosswalk:
  • RxCUI: 415974 - menthol 4 % Topical Gel
  • RxCUI: 415974 - menthol 0.04 MG/MG Topical Gel
    • Product Type:
    Human Otc Drug
    Labeler Name:
    Astonea Labs Private Limited
    Dosage Form:
    Gel - A semisolid3 dosage form that contains a gelling agent to provide stiffness to a solution or a colloidal dispersion.4 A gel may contain suspended particles.
    Administration Route(s):
  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
    • Active Ingredient(s):
  • MENTHOL 4 g/100g
    • Sample Package:
    No
    FDA Application Number:
    M017
    Marketing Category:
    OTC MONOGRAPH DRUG -
    Start Marketing Date:
    03-12-2024
    Listing Expiration Date:
    12-31-2025
    Exclude Flag:
    N
    Code Structure:

    The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 77338-007-04?

    The NDC Packaged Code 77338-007-04 is assigned to a package of 118.2 g in 1 tube of Astonea Cold Therapy, a human over the counter drug labeled by Astonea Labs Private Limited. The product's dosage form is gel and is administered via topical form.

    Is NDC 77338-007 included in the NDC Directory?

    Yes, Astonea Cold Therapy with product code 77338-007 is active and included in the NDC Directory. The product was first marketed by Astonea Labs Private Limited on March 12, 2024 and its listing in the NDC Directory is set to expire on December 31, 2025 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 77338-007-04?

    The 11-digit format is 77338000704. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    5-3-277338-007-045-4-277338-0007-04